Milestone Pharma
Milestone Pharma
Milestone Pharma supports global pharma and biotech teams with pharmaceutical quality research across analytical development, impurity and nitrosamine/NDSRI studies, E&L/CCIT, and reference standards. Our focus is simple: deliver reliable, regulatory-aligned data you can use for decisions and filings.
Milestone Pharma is a professional pharmaceutical quality research CRO. Guided by Science Enables Better Medicines, Technology Shapes Standards, we provide one-stop CMC, analytical and impurity solutions supporting FDA, EMA, NMPA global submissions.
With CNAS-accredited labs in Nanjing and Shanghai, we ensure data integrity and regulatory compliance. We have served 2,500+ global clients and delivered 10,000+ projects, covering small molecules, TIDES, biologics, nanomedicines, ATMP and drug-device systems.
We accelerate drug development and secure global market access for partners.
Key Metrics
-
10 +years of experience
-
290 +scientists & engineers
-
2500 +global customers
-
10000 +projects delivered
Development History
Corporate Culture
-
VISION
To provide comprehensive services for global customers to improve the quality standards of pharmaceutical and healthcare products.
-
MISSION
Continue building a quality research and development technology platform in line with global drug regulations and become industry leader to provide the best quality of services with the most complete capabilities and the best technologies.
-
VALUES
Integrity & Dedication
Working Together & Sharing Success
Doing the Right Thing
Doing It Right
Corporate Hornor
- 2025
- 2023
- 2022
- 2021
-
• Passed the on-site audit for EU Qualified Person Compliance Statement
• Re-passed FDA inspection
• Updated CNAS test items for the 2025 Chinese Pharmacopoeia
• Completed CNAS accreditation expansion for medical devices
-
• Passed FDA GMP inspection at laboratories in Shanghai and Nanjing
• Obtained filing certificate for Shanghai pathogenic microorganism laboratory, BSL-2 level
-
• Obtained CNAS accreditation (Shanghai site) , Certificate No. CNAS L17395
-
• Obtained CNAS accreditation (Nanjing site), Certificate No. CNAS L11112
Discuss My Project
Speak with an expert about your upcoming project to see how we can help you.
